Mylan's Hyzaar, Cozaar generics receive OK from FDA

PITTSBURGH The Food and Drug Administration has approved two generic drugs by Mylan for treating hypertension, Mylan said Friday.

The company announced the approval of losartan potassium and hydrochlorothiazide tablets in the 50/12.5-mg and 100/25-mg strengths, and losartan potassium tablets in the 25-mg, 50-mg and 100-mg strengths, generic versions of Merck’s Hyzaar and Cozaar, respectively. Mylan began marketing its version of Hyzaar in the 100/12.5-mg strength in April.

Various versions of Hyzaar in the two strengths had sales of around $570 million during the 12-month period ended in June, while versions of Cozaar had sales of $940 million, according to IMS Health.